Gap analysis at a drug production plant

Compliance / Security Life Sciences Belgium

Context and challenges

This client is a biopharmaceutical company that has several manufacturing sites located in several countries in Europe, Asia and America. This client is specialized in four therapeutic areas: Oncology, Gastroenterology, Neuroscience and Rare Diseases.

This client was facing several issues related to the product packaging, Artwork & BOM development and distribution, related to one of its production plant at Lessines. It generated 26 deviations and a customer complaint. Artwork includes several components, text and graphics, of the product packaging (for instance the box, the bottle label or the leaflet). BOM represents the Bill of Material that’s is to say a list of the different components needed for the product packaging.

This client has appointed Assystem Care to perform a gap analysis between the BOMs and the current active artworks using a specific project management approach.

Logo Assystem Care

Project scope

As-is process mapping and situational analysis on-site:

  • Interview of 3 teams managing the artwork process
  • Mapping of Artwork (including Client Artwork Management System), BOM and change request processes
  • Local review by all intervening departments
  • Review with global process owners on alignment & discrepancies

Roadmap of solutions:

  • Documentation : Update of procedures & support documents by the clarification of the different process flows, including Global and Local interactions and implications with the launch of Client Artwork Management System; creation of documents to facilitate new comers training: alignment, optimization of related procedures and documents.
  • Workshops and training: Organisation of awareness sessions and workshops to raise the competences and awareness of the artwork process
  • Gap analysis: Analysis of discrepancies between Artworks and BOMs: Review of the current active Artworks (4469) and BOMs (1050) to list all discrepancies, review and analysis of shipper and pallet labels designs and requirements
  • Reporting: preparation of a detailed report with all collected and analysed data

The missions were carried out with an Assystem Care proprietary solution and project management set of tools with standardised processes and methodologies.


Client benefits

  • Improved visibility related to potential gaps between artwork and BOM
  • Anticipation of errors and risks anticipation (packaging with wrong components or out-of-date) thanks to the remediation plan
  • Time savings related to the production of labels by country and product (simplification in the BOM list, time reduction to update the BOM) thanks to the production of a unique template of label for EU countries and printing directly on the production line
  • Clarification of the different process flows thanks to the optimisation of the documentation management
  • Enhanced search efficiency for input concerning Artwork & BOM development and distribution
  • Reduced rework and raised RFT (Right First Time)



weeks process mapping


months for implementing solutions


artworks analysed


BOMs analysed

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